Regulatory Guidance

Resources

Researchers are encouraged to include all segments of their community in research, including individuals whose primary language is not English. If the targeted study population of your study is likely to include subjects whose primary language is not English, the consent documents and subject provided materials must be translated into the appropriate language.

All documents requiring translation should be submitted to the IRB for approval of the English version prior to being translated. Upon completion, the translated version also needs to be submitted to the IRB for approval.

E&I offers translation services including:

Certified Translations

Certifications

Back-Translations

Please contact E&I for more information on translation services, pricing and timeframes.

Short Form Process Overview

If you believe the short form process is appropriate to your study, please contact the E&I office for additional guidance.

If, during the course of the study there is an occasional need for consent forms in other languages, it may be possible, with prior IRB approval, to use the short form consent process (45 CFR 46.117(b)(2) and 21 CFR 50.27(b)(2)).

The IRB determines if use of the short form consent process is appropriate and can be approved.

If a non-English speaking participant is initially consented for a study through an approved short form process, to the extent the study includes ongoing interventions or interactions with the participant, investigators will assess the feasibility of translating the full English consent into the participant's language whenever possible.

A description of the process used to obtain the short form consent should be included in the E&I application for review.

If the person obtaining consent is not fluent in the participant's language, a translator/interpreter must be present to assist in the consent process.

The translator/interpreter must be fluent in English and the language of the participant. A family member may be the translator/interpreter only if all other options for a non-related translator have been exhausted.

If the participant agrees to take part in the study, the following signatures are required: